Table 1

Primary, secondary and tertiary outcomes of the ATHENA study

Outcome	n	N	% (95% CI)
Primary
Feasibility of study (proportion of participants to those screened)	6	131	5 (2 to10)
Secondary
1. Applicability of videoconference assessments
(i) Eligible participants who begun videoconference testing after meeting eligibility criteria via telephone screening	12	38	32 (18 to 49)
(ii) Participants who begin videoconference testing at 4 weeks follow-up after being randomised	6	6	100 (54 to 100)
2. Applicability of the trial	4	6	67 (22 to 96)
3. Tolerability during follow-up at 6 weeks:
a. Adverse events of special interest	2	6
b. Participant withdrawal from treatment	0	6
4. Serious adverse event	0	6
Tertiary
1. Feasibility of videoconference neuropsychological assessments	12	12	100 (74 to 100)
2. Feasibility of completing CogState brief battery independently online
At screening	13	16	81 (54 to 96)
At week 4	5	6	83 (36 to 100)
3. Applicability of BP monitoring at home.	27	38	71 (54 to 85)

Primary—feasibility of the study: the denominator is the number of participants who commence the eligibility questionnaire via the TrialFacts screening form, and the numerator is the number of participants randomised.
Secondary—applicability of videoconference assessments: (i) the number of eligible participants that begin video conference testing (numerator), divided by the number of participants meeting eligibility criteria via telephone screening (denominator); (ii) the number of participants who begin videoconference testing at 4-week follow-up (numerator) over the number of randomised participants (denominator). (1) Applicability of the trial—The number of participants that complete all remote assessments (numerator) over number of randomised participants (denominator), (2) Tolerability during follow-up at 6 weeks: (a) Adverse Events of Special Interest (pre-specified options in the database were: headache, syncope/collapse, falls, pedal oedema/ankle swelling, hyperkalaemia, hypokalaemia, hyponatraemia). (b) Participant withdrawal from treatment. (3) Safety: any serious adverse event (SAE).
Tertiary: (1) Feasibility of completing the videoconference neuropsychological assessments—percentage of participants who complete videoconference neuropsychological assessments once testing has begun, (2) Feasibility of completing CogState brief battery independently online—the number of participants that complete the assessment (numerator) over the number that begin the assessment (denominator). (Note: Calculated at screening and at week 4), (3) Applicability of BP monitoring at home—The number that completed home BP self-measurement (numerator) over the number eligible from telephone screening (denominator). Remaining tertiary outcomes are effect size changes and presented in online supplemental tables.
ATHENA, Action To promote brain HEalth iN Adults; BP, blood pressure.